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Asphalion Knowledge Centre stands as a premier digital platform for professionals specializing in Biotech, Pharma, and Medtech sectors. We cater to the evolving needs of our global learner base by delivering insightful trning programs guided by industry experts acqunted with stringent EU and US regulatory standards.
Our courses are designed for flexibility, allowing learners worldwide to gn knowledge at their own pace. The focus is on promoting continuous professional growth through accessible education your career aspirations in healthcare innovation.
Explore our comprehensive course offerings below:
CTIS Mastery Bootcamp: Dive deep into the essentials of managing the Clinical Trials Information System CTIS portal, featuring interactive demonstrations and expert-led sessions.
Date: September 17
Language Format: English Online
ISO 13485 Internal Auditor Course: Acquire ISO 13485:2016 auditing skills, with a focus on quality management system compliance for medical devices.
Dates TBD
Language Format: English Online
PSURs Simplified: Expert-led analysis and risk assessment of key points in preparing Post-Approval Safety Summary PSURS documents for medicinal products and medical devices.
Dates TBD
Language: Spanish English Online
Elaborating the Safety Management Plan for Clinical Trials: Craft a robust safety plan to safeguard trial participants and ensure regulatory compliance.
Dates TBD
Language Format: English Online
ISO 13485 QMS Implementation: Learn, implement, mntn, and certify ISO 13485:2016 quality management systems for medical devices. Two intensive sessions are provided.
Dates TBD
Language Format: English Online
SME MAHs' Compliance Pathway: Tlored strategies for Small and Medium Enterprises SME to optimize pharmacovigilance compliance effectively.
Dates TBD
Language: Spanish Online
Post-Marketing Surveillance PMS under MDR Regulation: Master the requirements of market surveillance for medical devices under the Medical Device Regulation.
Dates TBD
Language Format: English Online
Empowering Pharmacovigilance with Digital Tools: Strengthen your skills in digital literature searches, crucial for mntning compliance and staying informed.
Dates TBD
Language Format: Spanish English Online
Basics of Clinical Affrs for Medical Devices: Focus on ensuring compliance and patient safety with expert guidance.
Dates TBD
Language Format: English Online
Borderline Cases in Medical Device Classification: Learn to classify medical devices according to EU regulations, tackling complex borderline scenarios.
Dates TBD
Language Format: English Online
ISO 14971 Risk Management for Medical Devices: Gn insights into conducting a comprehensive risk assessment and management throughout the product lifecycle.
Dates TBD
Language Format: English Online
Explore our services further or contact us directly to tlor solutions that meet your specific learning objectives in healthcare innovation.
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Biotech Pharma Medtech Training Courses Online CTIS Mastery Bootcamp Portal Education EU Standards ISO 13485 Internal Auditor Medical Devices Course PSURs Simplified Post Approval Safety Summary Guidance Compliance Enhancements ISO 13485 Quality Management Implementation Pharmacovigilance SME MAHs Effective Compliance Strategies